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COPDNCT01739751

Physical Activity Enhancement Using Pedometers in COPD

A study testing pedometers in people with COPD, run by University of Chile at 1 site in Chile.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Physical activity is reduced in COPD affecting morbidity and mortality and the usual advice is not good enough to increase the physical activity level. The aim of the study is to determine the effects of pedometers in the physical level in COPD patients. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
COPD
What is being tested?
pedometers
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteChile
Study dates
Jan 2011to Apr 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • COPD diagnosis according to GOLD guidelines
  • Pack year Index equal or more than 10
  • smoking suspended > 2 months
  • older than 40 years old,

Who cannot join

  • any chronic condition that does not allow walking
  • participation in a rehabilitation program
  • Acute exacerbation in the last two months

Trial locations and contacts

1 site in 1 country.

Chile1 site

  • Hospital Clínico Universidad de Chile

    Santiago, Santiago Metropolitan, 8380456

Other trials in Chile

About this study

Official title: Effect of a Program of Physical Activity Enhancement Using Pedometers in Chronic Obstructive Pulmonary Disease

Physical activity is reduced in COPD affecting morbidity and mortality and the usual advice is not good enough to increase the physical activity level. The aim of the study is to determine the effects of pedometers in the physical level in COPD patients.

Read the detailed description

Physical activity is reduced in COPD patients and has a negative effect in the morbidity and mortality of this condition. Unfortunately, usual advice is not good enough to reverse the sedentary condition in COPD patients. Pedometers are broadly used to measure and to enhance physical activity in COPD but their effects in COPD are not well known. The aim of the study is to determine the effects of a program using pedometers as a feedback in stable ex smokers COPD patients. Patients are recruited for a 3 months individual program promoting daily physical activity enhancement and are randomly assigned either to a pedometer-based program (experimental group) or to usual care (control group, the measurements at the beginning and at the end of the study are: anthropometrics, Spirometry, dyspnea, quality of life, exercise capacity and the average one week daily steps. Also the number of acute exacerbations during the follow up are recorded.

Conditions
COPD
Being tested
pedometers
Keywords
COPD, Physical activity, Pedometers, steps, non pharmacological treatment, rehabilitation, exercise
Medical subject headings
Pulmonary Disease, Chronic Obstructive, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pedometersDevice

    Also called PD 724

    portable device that estimate the number of steps walked daily

Study groups in NCT01739751
Study groupRoleWhat they receive
Control GroupNo interventionPatients without feedback of a pedometers, followed for 3 months
PedometersExperimentalWith a program of physical activity enhancement using pedometers as a feedback
Receives: Device: pedometers

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. effect in average steps walked daily

    Comparison between both groups in the difference of the average of steps walked daily at final evaluation with the basal evaluation

    Measured: 3 months

Secondary outcomes (3)

  1. six minute walking distance

    Comparison between groups in the difference of the distance( meters) in the six minute walking test in the final evaluation with the basal evaluation

    Measured: 3 months

  2. score in the Saint George Respiratory Questionnaire

    Comparison between groups in the difference of the score of the SGRQ at the final evaluation in comparison with the basal evaluation

    Measured: 3 months

  3. Score of the COPD Assessment Test (CAT)

    Comparison between groups in the difference of the CAT score at the final evaluation with the basal evaluation

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2012 (estimated)
  2. Study startJan 2011
  3. Primary completionMar 2013 (estimated)
  4. Study completionApr 2013 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01739751
Sponsor's protocol ID
SA10i20022
Status last verified
Nov 2012
First submitted
29 Nov 2012
Last updated
4 Dec 2012
Results posted
No
Data monitoring committee
No

Publications

  • Bravata DM, Smith-Spangler C, Sundaram V, Gienger AL, Lin N, Lewis R, Stave CD, Olkin I, Sirard JR. Using pedometers to increase physical activity and improve health: a systematic review. JAMA. 2007 Nov 21;298(19):2296-304. doi: 10.1001/jama.298.19.2296.

    PubMed 18029834

Questions about this trial

What is this clinical trial studying?

A study testing pedometers in people with COPD, run by University of Chile at 1 site in Chile.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

effect in average steps walked daily (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01739751, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2012; AzTrials last refreshed its copy on 27 Oct 2026.

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